BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONMED

    MDR report key: 21376779 · Received February 13, 2025

    Report

    Report Number
    21376779
    Event Type
    Malfunction
    Date Received
    February 13, 2025
    Date of Event
    January 21, 2025
    Report Date
    February 6, 2025
    Manufacturer
    UNIMAX MEDICAL SYSTEMS INC.
    Product Code
    GCJ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    CONMED MINI ENDO POCKET BROKE AND ARM SNAPPED IN HALF WHILE INSIDE OF PATIENT. PIECES WERE RETRIEVED. MANUFACTURER RESPONSE FOR LAPAROSCOPE, GENERAL PLASTIC SURGERY, CONMED (PER SITE REPORTER). WAITING FOR THEIR RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125416 CONMED LAPAROSCOPE, GENERAL PLASTIC SURGERY GCJ UNIMAX MEDICAL SYSTEMS INC. SB534 6252006036

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Female